Catheters find their use in many different medical applications, such as urinary catheters for bladder drainage.
These urinary catheters are used in a variety of populations, including the elderly, stroke victims, spinal cord-injured patients, post-operative patients and those with obstructive uropathy. Despite adherence to sterile guidelines for the insertion and maintenance of urinary catheters, catheter-associated infections continues to pose a major problem. When medical devices such as a catheter is introduced into the human cavity, the normal human defense barrier may be penetrated, which can result in introduction of bacteria, fungi, vira, or tissue-like or multiple organized cells. Urinary tract infection (UTI), for instance, is a problem associated with the use of urinary catheters, including hydrophilic catheters with hydrophilic coatings for intermittent use. It is estimated that almost one-quarter of hospitalized spinal cord-injured patients develop symptomatic UTI during their hospital course. Gram-negative bacilli account for almost 60-70%, enterococci for about 25% and Candida species for about 10% of cases of UTI. It is well known that persons practicing intermittent urethral catheterization as a daily routine often have problems with symptomatic UTI.
In order to maintain the catheter in a clean and preferably sterile condition, each catheter is normally pre-packed in a receptacle by the manufacturer.
Additionally, in order to facilitate the use and to improve cleanliness of the catheter, the assemblies have in recent years developed to comprise a rupturable wetting fluid pouch or container as well, where wetting of the catheter may be performed without the use of externally supplied water, and without breaking the sealed condition of it until intended use of the catheter. Such assemblies are disclosed in for instance WO 97/26937, WO 01/43807 and WO 98/11932. Further, so called “ready-to-use” catheters have been proposed, where the catheter is arranged in the receptacle together with a wetting fluid in such a way that the catheter is maintained in a wetted, activated condition by said fluid. Such ready-to-use catheter assemblies are disclosed in for instance WO 00/47494 and WO 98/19729.
Further, in order to maintain sterility and cleanness of the catheter, the catheter may be coated with an antimicrobial compound for prevention of bacterial infection. US 2006/0240069, for instance, discloses a use of at least one salt of organic acid(s), and preferably a benzoate or a sorbate, as an antimicrobial agent. The compound described can also be incorporated in a wetting fluid, usable for providing low-friction surface character of a hydrophilic coating of a catheter by treatment with the wetting fluid, for making the hydrophilic coating antimicrobial when activated by the wetting fluid. Further, WO 00/09173 discloses a stabilized composition having antibacterial, antiviral and/or antifungal activity characterized in that it comprises a silver compound. Light stabilized silver composition can be introduced into catheters or similar medical devices.
However, although antimicrobial coating as well as the maintenance of the catheter in a sterile condition serve to inhibit bacterial growth and prevent bacterial infections, insertion of the catheter into the urethra continues to constitute a risk for introduction of bacteria into the human body. One of the causes for this is that bacteria may still be transferred to the catheter during withdrawal of the catheter from its receptacle. Specifically, the withdrawal from the receptacle pose a problem when the outer surface of the receptacle is prone to come into contact with the catheter as the catheter is withdrawn, thus enabling bacteria from the receptacle to come into contact with the catheter.
Therefore, there is still a need for improved means for inhibiting bacterial infections and similar diseases related to growth and transfer of microbes in the use of catheters.